A Clinical Trial of Multiple Formulations of MK-4082 in Healthy Overweight and Obese Participants (MK-4082-007)
A Study to Evaluate the Relative Bioavailability of Multiple Formulations of MK-4082 in Overweight/Obese Participants
Researchers are looking for new weight loss medicines for people with higher body weight. The study medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a study medicine to people with a health condition, researchers first do studies to find a safe dose level (amount) and formulation (version) of the study medicine that can be used in future studies.
The goals of this study are to learn about:
The safety of different formulations of MK-4082 and if people tolerate them What happens to different formulations of MK-4082 in a person's body over time
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
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California
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Chula Vista, California, Vereinigte Staaten, 91911
- ProSciento Inc. ( Site 0002)
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Texas
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San Antonio, Texas, Vereinigte Staaten, 78232
- ICON Early Phase Services ( Site 0003)
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Is in good health
- Has a body mass index (BMI) between 25 and 40 kg/m^2, inclusive and weighs at least 60 kg
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has a history of previous surgical treatment for obesity that may induce malabsorption, history of bowel resection >20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss
- Has an individual or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Panel A Sequence 1
Participants will be administered daily oral doses of MK-4082 formulation 1 (F1) and MK-4082 formulation 2 (F2) in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F2 for 7 days followed by daily oral doses of MK-4082 F1 for 7 days. |
Oral Tablet Oral Tablet |
|
Experimental: Panel A Sequence 2
Participants will be administered daily oral doses of MK-4082 F1 and MK-4082 F2 in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F1 for 7 days followed by daily oral doses of MK-4082 F2 for 7 days. |
Oral Tablet Oral Tablet |
|
Experimental: Panel B Sequence 1
Participants will be administered daily oral doses of MK-4082 F1 and MK-4082 formulation 4 (F4) in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F4 for 7 days followed by daily oral doses of MK-4082 F1 for 7 days. |
Oral Tablet Oral Tablet |
|
Experimental: Panel B Sequence 2
Participants will be administered daily oral doses of MK-4082 F1 and MK-4082 F4 in a fixed sequence over the first 4 weeks, with only one formulation administered on any given day. In week 5, participants will be administered daily oral doses of MK-4082 F1 for 7 days followed by daily oral doses of MK-4082 F4 for 7 days. |
Oral Tablet Oral Tablet |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
Zeitfenster: Up to approximately 8 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. |
Up to approximately 8 weeks
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Zeitfenster: Up to approximately 6 weeks
|
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported. |
Up to approximately 6 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-4082
Zeitfenster: At designated timepoints (up to 24 hours postdose)
|
Blood samples will be collected to determine the AUC0-24 of MK-4082. |
At designated timepoints (up to 24 hours postdose)
|
|
Plasma Concentration at 24 Hours (C24) of MK-4082
Zeitfenster: At designated timepoints up to 24 hours postdose
|
Blood samples will be collected to determine the C24 of MK-4082. |
At designated timepoints up to 24 hours postdose
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Medical Director, Merck Sharp & Dohme LLC
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 4082-007
- MK-4082-007 (Andere Kennung: MSD)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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